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NCT05083442: LLLT

Low-level Laser and Lifestyle Modifications

Completed NA Results posted Last updated 3 April 2025
What this trial tests

NA trial testing Low Level Laser Therapy in Overweight and Obesity in 60 participants. Completed in 30 December 2024.

Timeline
1 June 2022
Primary endpoint
30 April 2024
30 December 2024

Quick facts

Lead sponsorMayo Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date1 June 2022
Primary completion30 April 2024
Estimated completion30 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Overweight and Obesity or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Fat Mass From Baseline to 6 Weeks Primary · 6 weeks

The change in fat mass from baseline to the end of treatments at 6 weeks

GroupValue95% CI
Group 1 - LLLT-1.3± 1.5
Group 2 - SHAM-2.0± 2.4
Change in Waist Circumference From Baseline to 6 Weeks Primary · 6 weeks

The change in waist circumference from baseline to the end of treatments at 6 weeks

GroupValue95% CI
Group 1 - LLLT-1.8± 3.5
Group 2 - SHAM-1.8± 4.0

Adverse events — posted to ClinicalTrials.gov

Time frame: AE's were collected over the 6 weeks of the LLLT intervention.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1 - LLLT
Serious: 0/30 (0%)
Deaths: 0/30
Group 2 - SHAM
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (3 terms — click to expand)

ReactionSystemGroup 1 - LLLTGroup 2 - SHAM
Loose StoolGastrointestinal disorders
muscle contraction/tinglingMusculoskeletal and connective tissue disorders
stomach/gas painGastrointestinal disorders

Data from ClinicalTrials.gov NCT05083442 adverse events section.

Sponsor's own description

The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Low Level Laser Therapy

Trials testing the same drug.

Other recruiting trials for Overweight and Obesity

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05083442.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing